Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients

Evaluation of Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients: an Observational and Prospective Clinical Study

The goal of this observational and prospective study is to investigate changes in physical performance, lung function, respiratory and peripheral muscle strength in patients during the postoperative period following pulmonary endarterectomy (PET).

Study Overview

• Status: Recruiting
• Conditions: Physical Disability; Chronic Thromboembolic Pulmonary Hypertension; Fragility

Detailed Description

This study aims to investigate the physical changes in patients undergoing pulmonary endarterectomy (PET). It will observe alterations in physical performance, lung function, and muscle strength during the postoperative period. This study, observational and prospective, will include individuals aged ≥18 scheduled, evaluating them preoperatively, post-intensive care unit discharge, before hospital discharge and after six months . Assessments involve tests like the Six-minute walk test, Short Physical Performance Battery, One-minute sit-to-stand test, manovacuometry, dynamometry, spirometry and Clinical Frailty Scale to identify frailty and measure muscle and lung function. The study also aims to explore predictive variables for functional loss during hospitalization.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Rafael M Ianotti, PT; Phone Number: +55 11 26615319; Email: rafael.ianotti@hc.fm.usp.br

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05403-000
      • Recruiting
      • Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
      • Sub-Investigator: Orival Freitas Filho, MD
      • Sub-Investigator: Fabio B Jatene, MD,PhD
      • Sub-Investigator: Kelly CO Abud, PT, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients in the preoperative period of elective pulmonary endarterectomy susrgery.

Description

Inclusion Criteria:

• Age ≥ 18 years
• Both genders
• Elective pulmonary endarterectomy surgery
• Absence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the preoperative period.

Exclusion Criteria:

• Reoperation for any reason
• Presence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the postoperative period.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate changes in physical performance measured by Six-Minute Walk Test.	Measures: the assessment will take place in a flat 30-meter corridor, marked every 1 meter with non-slip flooring, and the patient will be instructed to walk for six minutes as fast as possible.	Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery.
To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB).	Measure: global score	Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after surgery.
To investigate changes in physical performance by 1-minute sit-to-stand test (1-MSTST).	Measure: number of 1-MSTST repetitions.	Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery
To investigate changes in peripheral muscle strength.	Measure: hand grip strengh (Kgf).	Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery
To investigate changes in respiratory muscle strength:	Measures: manovacuometry (cmH2O)	Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery
To investigate changes in lung function test measure by spirometry:		Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery
To investigate frailty by Clinical Frailty Scale (CFS)	The minimal value is 1 and the maximal is 9 in which the lowest scores mean worse outcomes.	Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To explore potential preoperative and immediate postoperative risk factors as predictors of functional loss.	Measures: Occurrence of comorbidities and clinical variables associated with functional decline.	Baseline (one day before the surgery) during the immediate postoperative period.
To investigate changes in hemodynamic and respiratory variables during the funcional tests.		Immediateley before and after each functional test.

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Rafael M Ianotti, PT, Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): May 2, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Spirometry; Muscular strength; Six-minute walk test; Short Physical Performance Battery; Pulmonary Endarterectomy Surgery; One-minute sit-to-stand test
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Frailty; Hypertension, Pulmonary
• Other Study ID Numbers: CAAE: 73520523.7.0000.0068

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No